Apparatus and method for heart valve repair

ABSTRACT

A device  10  for gathering tissue in a patient includes an elongated catheter  14  and a capture assembly  13  at a distal portion of the catheter. The capture assembly has a closed side  18  and a door  20  rotatable between an open condition and a closed condition. The closed side  18  of the capture assembly  13  and the door  20  in the closed condition may collectively define a tissue capturing compartment  19.  Movement of the door  20  from the open condition to the closed condition adjacent the tissue may capture a portion  44  of the tissue in the tissue capturing compartment  19.  A clip may then be applied from the capture assembly  13  to the captured tissue  44  to hold the tissue substantially in a gathered configuration.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of the filing date of U.S.Provisional Patent Application No. 61/590,475 filed Jan. 25, 2012, thedisclosure of which is hereby incorporated by reference herein.

BACKGROUND OF THE INVENTION

The present invention is related to tissue repair, and more particularlyto devices, systems, and methods for minimally invasive repair of aheart valve leaflet.

Properly functioning heart valves can maintain unidirectional blood flowin the circulatory system by opening and closing, depending on thedifference in pressure from one side of the valve to the other. The twoatrioventricular valves (mitral and tricuspid valves) are multicuspedvalves that prevent backflow from the ventricles into the atria duringsystole. They are anchored to the wall of the ventricle by chordaetendineae, which prevent the valve from inverting.

The mitral valve is located at the gate of the left ventricle and ismade up of two leaflets and a diaphanous incomplete ring around thevalve, known as the mitral valve annulus. When the valve opens, bloodflows into the left ventricle. After the left ventricle fills with bloodand contracts, the two leaflets of the mitral valve are pushed upwardsand close, preventing blood from flowing back into the left atrium andthe lungs.

Mitral valve prolapse is a type of myxomatous valve disease in which theabnormal mitral valve leaflets prolapse (i.e., a portion of the affectedleaflet may be billowed, loose, and floppy). Furthermore, the chordaetendineae may stretch and thus become too long, or the chordae tendineaemay be ruptured. As a result, the valve is not properly held in a closedcondition. As a result of being stretched, the unsupported valve leafletbulges back, or “prolapses,” into the left atrium like a parachute.Thus, as the ventricle contracts, the abnormal leaflet may be propelledbackwards, beyond its normal closure line into the left atrium, therebyallowing blood to return to the left atrium and the lungs.

Mitral valve prolapse causes mitral regurgitation. Isolated posteriorleaflet prolapse of the human heart mitral valve, i.e. prolapse of asingle leaflet, is the most common cause of mitral regurgitation. Theexact cause of the prolapse is not clear. Untreated mitral regurgitationmay lead to congestive heart failure and pulmonary hypertension.

Despite the various improvements that have been made to devices andmethods for mitral valve leaflet repair, there remain some shortcomings.For example, conventional methods of treating mitral valve prolapseinclude replacement of the mitral valve, clipping the two mitral valveleaflets to one another, and resection of the prolapsed segment usingopen heart surgery. Such surgical methods may be invasive to the patientand may require an extended recovery period.

There therefore is a need for further improvements to the currenttechniques for treating heart valve leaflet prolapse specifically, andfor gathering tissue in a patient generally. Among other advantages, thepresent invention may address one or more of these needs.

BRIEF SUMMARY OF THE INVENTION

Methods and devices for gathering tissue in a patient are disclosed. Amethod of gathering tissue in a patient may include inserting anelongated device into the patient to a position adjacent the tissue, thedevice including a capture assembly having a closed side and a doorrotatable between an open condition and a closed condition, the closedside and the door in the closed condition collectively defining a tissuecapturing compartment. The door may then be moved from the closedcondition to the open condition and engaged against the tissue. The doormay be closed against the tissue to capture a portion of the tissueinside the tissue capturing compartment, the captured tissue beingformed into a gathered configuration. At least one clip from the captureassembly may be applied to the captured tissue so as to hold thecaptured tissue substantially in the gathered configuration.

The tissue may be a heart valve leaflet. The capture assembly mayinclude a spring element coupled to the door and biased to move the doorto the closed condition. The door may include at least one prongprojecting therefrom, and the closing step may include grasping thecaptured tissue with the at least one prong. The door may include aportion with serrations, and the closing step may include grasping thecaptured tissue with the serrations. The device may include a deploymentelement attached to the door and operable by a user, and the moving stepmay include pulling the deployment element to rotate the door to theopen condition.

The capture assembly may include first and second doors rotatablebetween open and closed conditions, and the closing step may includeclosing the first and second doors against the tissue to capture theportion of the tissue inside the tissue capturing compartment. The clipmay be biased to a substantially round condition and may be engaged withthe door to hold the clip in an open condition, and the applying stepmay include releasing the clip from engagement with the door, wherebythe clip may move from the open condition to the substantially roundcondition. The device may include an actuating rod movable relative tothe at least one clip, and the applying step may include moving theactuating rod to contact the at least one clip and releasing the atleast one clip for application to the captured tissue.

A device for gathering tissue in a patient may include an elongatedcatheter having a proximal portion and a distal portion and a captureassembly at the distal portion of the catheter. The capture assembly mayinclude a closed side and a door rotatable between an open condition anda closed condition, the closed side and the door in the closed conditioncollectively defining a tissue capturing compartment. The door may beoperable to capture a portion of the tissue in a gathered configurationwithin the tissue capturing compartment.

The device may also include a spring element coupled to the door andbiased to move the door to the closed condition. The door may have oneedge rotatably connected to the closed side of the capture assembly anda free edge opposite the one edge. The free edge may include at leastone prong projecting therefrom. The free edge may include a plurality ofserrations. The device may also include a deployment element attached tothe door and extending through the elongated catheter. The captureassembly may include first and second doors rotatable between open andclosed conditions. The first and second doors may be operable to capturethe portion of the tissue in a gathered configuration within the tissuecapturing compartment.

The device may also include at least one clip releasably held in thetissue capturing compartment and adapted to be applied to the capturedtissue for holding the captured tissue in the gathered configuration.The clip may be biased to a substantially round condition and may beengaged with the door to hold the clip in an open condition. The clipmay have a first end and a second end, and the door may include a slot.The first end of the clip may be engaged in the slot. Movement of thedoor to the open condition may create a biasing force in the cliptending to move the door to the closed condition.

The device may also include an actuating rod slidably disposed in thetissue capturing compartment. The actuating rod may have a laterallyprojecting bump, and the clip may be at least partially held in a travelpath of the bump. Movement of the bump through the travel path may causethe bump to release the clip for application to the captured tissue. Thebump may have an oval cross-section, and a portion of the actuating rodadjacent the bump may have a round cross-section that is smaller thanthe oval cross-section in at least one direction.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present invention will now be discussed withreference to the appended drawings. It is appreciated that thesedrawings depict only some embodiments of the invention and are thereforenot to be considered limiting of its scope.

FIG. 1 is a diagrammatic perspective view of the posterior leaflet of amitral valve;

FIG. 2A is a perspective view of the distal portion of one embodiment ofa device for gathering tissue of a heart valve leaflet, shown with thedoors in the fully closed condition;

FIG. 2B is a perspective view of the distal portion of the device ofFIG. 2A, shown with the doors in the fully open condition;

FIG. 2C is a cross-sectional view of the device of FIG. 2A, taken alongline 2C-2C of FIG. 2A;

FIGS. 3, 4, 5A, 6, and 7 are diagrammatic views showing the steps ofoperating the device of FIG. 2A for gathering of heart valve leaflettissue and applying clips to same;

FIG. 5B is a cross-sectional view of the device and gathered tissue,taken along line 5B-5B of FIG. 5A;

FIG. 8A is a perspective view of another embodiment of a device forgathering tissue of a heart valve leaflet, shown with the doors in thefully closed condition; and

FIG. 8B is a perspective view of the device of FIG. 8A, shown with thedoors in the fully open condition.

DETAILED DESCRIPTION

As used herein, the terms “proximal” and “distal” are to be taken asrelative to a user (e.g., a surgeon or an interventional cardiologist)using the disclosed devices. “Proximal” is to be understood asrelatively close to the user and “distal” is to be understood asrelatively farther away from the user. The invention will be describedin connection with the repair of a mitral valve leaflet, but it may beuseful in the repair of other types of cardiac valves or in thegathering and clamping of other types of loose body tissue.

Referring to FIG. 1, an exemplary mitral valve 1 includes a posteriorleaflet 2 and an anterior leaflet 3. The leaflets 2 and 3 extend from anannulus 4 to a coaption line 5 where the leaflets meet. The posteriorleaflet 2 has an upper portion 6 that is generally perpendicular to thedirection of blood flow through the valve 1 and extends between theannulus and the coaption line 5. Additionally, the posterior leaflet 2has a lower portion 7 that is generally parallel to the direction ofblood flow through the valve 1 and extends below the coaption line 5.The posterior leaflet 2 has three scalloped portions P1, P2, and P3, anyof which may include a portion that is billowed, loose, or floppy, andtherefore be the cause of a prolapse condition of the valve. Theinventive devices, systems, and methods described herein may be adaptedto repair such a billowed, loose, or floppy portion of the posteriorleaflet 2 or the anterior leaflet 3. Chordae tendineae 8 (FIG. 3) mayconnect the lower portion 7 of the posterior leaflet 2 to the papillarymuscles of the left ventricle 9.

Referring to FIGS. 2A-2C, an exemplary device 10 for gathering heartvalve leaflet tissue includes an elongated catheter 14 adapted to beinserted through the apex of a human heart so that a capture assembly 13at a distal portion of the catheter may reach the patient's mitral valve1 for repair thereof. The capture assembly 13 preferably has an outerprofile and cross-sectional shape similar to that of the catheter 14.

The capture assembly 13 includes a proximal end wall 15, a distal endwall 16, a closed side 18 extending between the proximal and distal endwalls, and a pair of hinged doors 20. An atraumatic tip 11 is positionedat the distal end of the capture assembly 13. The capture assembly 13may be made of one or more echogenic materials so as to be more easilyvisualized inside a patient using three-dimensional echocardiography.

Each door 20 is rotatably coupled to the closed side 18 at an innerlongitudinal edge 28 of the door. As shown in FIGS. 2A-2C, each door 20may be coupled to the closed side 18 by a hinge that includes a pinextending through apertures in the door and the closed side, but theinvention contemplates any other coupling mechanism that allows thedoors 20 to be rotatably coupled to the closed side, such as a livinghinge.

The doors 20 are rotatable relative to the closed side 18 of the captureassembly 13 between a closed condition shown in FIG. 2A and a fully opencondition shown in FIG. 2B. A free longitudinal edge 32 of each door 20may include prongs 30 adapted to engage with corresponding recesses 34in the free longitudinal edge 32 of the opposite door when the doors arein the closed condition. In the closed condition of the doors 20, atissue capturing compartment 19 is defined between the doors and theclosed side 18 of the capture assembly 13.

The capture assembly 13 further includes one or more clips 40, the endsof which are engaged in corresponding slots 36 in the doors 20. The endsof each clip 40 may be formed with a prong 42 adapted to embed in theleaflet tissue when the clip is deployed. The clips 40 may be made of amemory metal and may be biased to curl into a substantially roundconfiguration. When the ends of the clips 40 are engaged in the slots36, this biasing force biases the doors 20 to the closed condition.

A deployment wire 50 for opening the doors 20 may extend through thecatheter 14 from a proximal end connected to an actuating mechanism (notshown) located outside of the patient's body, and through the proximalend wall 15 of the capture assembly 13 into the tissue capturingcompartment 19. The deployment wire 50 may then travel through acontainment tube 58 positioned adjacent the inside surface of the closedside 18 of the capture assembly 13, and through an aperture 54 in theclosed side to the exterior of the capture assembly. The distal end ofthe deployment wire 50 may have two arms 51 that wrap circumferentiallyaround the outside of the closed side 18 of the capture assembly 13 andattach to the two doors 20 at attachment locations 52 near the free edge32 of each door. As will be explained below, movement of the deploymentwire 50 in the proximal direction moves the doors 20 from the closedcondition to the open condition.

An actuation rod 60 for releasing the clips 40 may extend through thecatheter 14 from a proximal end connected to an actuating mechanism (notshown) located outside of the patient's body, and through an aperture 68in the proximal end wall 15 of the capture assembly 13 into the tissuecapturing compartment 19. The actuation rod 60 may be bent to define abump 64 that curves laterally away from the longitudinal axis of theactuation rod. The actuation rod 60 is slidable between an initialposition with its distal end 62 extending through an aperture 66 in thedistal end wall 16 and into the atraumatic tip 11 (FIG. 2B), and adeployed position with its distal end located within the tissuecapturing compartment 19. An example of a partially-deployed position ofthe actuation rod 60 is shown in FIG. 6. The bump 64 is adapted tocontact the clips 40 when the actuation rod 60 is slid proximally withinthe compartment 19.

To use the device 10 for gathering heart valve leaflet tissue, a usermay first pull the deployment wire 50 proximally to open the doors 20.The clips 40 may then be loaded into the tissue capturing compartment 19around the actuation rod 60, such that each clip is located between theactuation rod and the closed side 18 of the capture assembly 13, withthe prongs 42 of each clip engaged in the corresponding slots 36 in thedoors 20. After the clips 40 have been loaded into the tissue capturingcompartment 19, the deployment wire 50 may be released, such that thebiasing force exerted by the clips will pull the doors 20 into theclosed condition.

The device 10 may then be inserted into the patient and advanced untilthe capture assembly 13 is located adjacent the mitral valve, preferablyusing a transseptal approach. That is, the device 10 may be advancedfrom the femoral vein through the iliac vein, the inferior vena cava,and the right atrium, and across the septum wall into the left atrium,until the capture assembly 13 extends between the posterior leaflet 2and the anterior leaflet 3 of the mitral valve 1, as shown in FIG. 3.This route requires the least amount of bending or turning and providesthe most direct route to the mitral valve leaflets. Minimizing thenumber of turns may facilitate the rotational control of the captureassembly 13. If the capture assembly 13 includes echogenic materials, itmay be guided to a position against a leaflet near the coaption line 5using the assistance of three-dimensional echocardiography.

Once the capture assembly 13 has been positioned near the coaption line5, the user may pull the deployment wire 50 proximally to move the doors20 to the fully open condition. To keep the doors 20 open, thedeployment wire 50 may be temporary locked relative to the closed side18 of the capture assembly 13, for example, using a locking feature of acontrol handle (not shown) located at the proximal end of the catheter14.

Referring to FIG. 4, with the doors 20 open, the capture assembly 13 maybe positioned adjacent the lower portion 7 of the posterior leaflet 2 sothat the exposed tissue capturing compartment 19 faces the posteriorleaflet. The capture assembly 13 may then be pressed against the lowerportion 7 of the posterior leaflet 2 to engage the prongs 30 of thedoors 20 in the tissue of the posterior leaflet.

Subsequently, the user may release the deployment wire 50, so that theclips 40 are free to begin to curl into a substantially roundconfiguration according to their bias, thereby closing the doors 20against the tissue of the posterior leaflet 2 until the doors attain thepartially open condition shown in FIGS. 5A and 5B. As the doors 20close, the prongs 30 in the longitudinal edges 32 of the doors may graspand/or piece the leaflet tissue, pulling it toward the compartment 19.When the doors 20 are in the partially open condition and engaged withthe tissue of the posterior leaflet 2, some of the tissue of theposterior leaflet will be captured inside of the tissue capturingcompartment 19 and within the diameter of the clips 40. This capturedtissue 44 may form a pleat 46 extending substantially along thelongitudinal axis of the tissue capturing compartment 19.

Referring to FIG. 6, the user may then release the clips 40 intoengagement with the captured tissue 44 by sliding the actuation rod 60proximally within the compartment 19. As the actuation rod 60 slidesproximally, the bump 64 first contacts a distal clip 40 a. The bump 64provides a force in a lateral direction transverse to the longitudinalaxis of the compartment 19, thereby forcing the distal clip 40 a towardthe closed side 18 of the compartment. As the clip 40 a is displaced,the prongs 42 of the clip disengage from the slots 36. Only a smalltransverse movement of each clip 40 is required to disengage the prongs42 from the corresponding slots 36. Once the clip 40 a is disengagedfrom the slots 36, the clip is free to continue to curl into asubstantially round configuration according to its bias, and the prongs42 of the clip engage and may become embedded in the captured tissue 44on either side of the pleat 46.

After the distal clip 40 a has been applied to the captured tissue 44,the user may slide the actuation rod 60 further proximally, therebydisengaging a proximal clip 40 b from the slots 36 and causing theprongs 42 of the proximal clip to engage and possibly embed in thecaptured tissue 44 in the same manner as the distal clip 40 a.

Referring to FIG. 7, once the clips 40 have been applied to the lowerportion 7 of the posterior leaflet 2, the user may pull the deploymentwire 50 proximally to move the doors 20 to a sufficiently open conditionto allow the user to move the capture assembly 13 away from theposterior leaflet and disengage the prongs 30 of the doors 20 from thecaptured tissue 44.

After disengagement of the doors 20 from the posterior leaflet 2, thedoors may be moved into the fully closed condition for withdrawal fromthe patient. To close the doors 20 after the clips 40 have been appliedto the tissue, a memory feature may be included in the capture assembly13 to provide a force according to its bias that tends to close thedoors. Examples of such a memory feature may include a living hinge thatcouples the doors to the closed side 18 of the capture assembly 13 or aleaf spring 148, such as that shown in FIG. 8B. The procedure describedabove may be repeated to apply one or more additional clips 40 onto thesame posterior leaflet 2.

An alternative embodiment of a device 110 for gathering heart valveleaflet tissue is shown in FIGS. 8A and 8B. The device 110 is similar tothe device 10 described above, but the device 110 includes alternateversions of the doors, the actuation rod, and the memory door-closingfeature.

Rather than having doors with prongs and corresponding recesses at theirfree edge, the device 110 has doors 120 having a serrated edge 132. Theserrated edges 132 of the doors 120 are adapted to become interleavedwith one another when the doors are moved to the closed condition shownin FIG. 8A. The serrated edges 132 together define a longitudinalexternal recess 134 when the doors 120 are in the closed condition.

The actuation rod 160 of the device 110 is similar in function to theactuation rod 60 described above. The actuation rod 160 has a generallyoval cross-section along its entire length, with the exception of anelongated portion 165 spaced from the distal end 162 of the actuationrod that has a substantially round cross-section that is smaller thanthe oval cross-section in at least one direction. As a result of thisdifference in cross-sections, a bump 164 is defined on the distal end162 of the actuation rod 160 that extends farther in a lateral directionfrom the longitudinal axis of the actuation rod than the elongatedportion 165. When the actuation rod 160 is in the initial position, theelongated portion 165 is disposed adjacent the clips 140. When the userslides the actuation rod 160 proximally, the bump 164 contacts the clips140 and forces them toward the closed side 118 of the compartment 119,disengaging the clips from the slots 136.

The aperture 166 at the distal end of the compartment 119 and theaperture 168 at the proximal end of the compartment have oval shapesthat correspond to the oval shape of the actuation rod 160. The matchingof these oval shapes prevents the actuation rod 160 from rotating,thereby keeping it oriented with the bump 164 facing toward the clips140.

The device 110 further includes a leaf spring 148 formed from a memorymetal so as to be biased to the closed position shown in FIG. 8A. Theends of the leaf spring 148 are engaged in opposing slots 149 in thedoors 120 so that the leaf spring provides a force according to its biasthat tends to close the doors.

In the foregoing, particular structures have been described that areadapted to gather, secure, and repair heart valve leaflet tissue. Theinvention also contemplates the use of alternative structures for suchpurposes, including structures having different lengths, shapes, andconfigurations. For example, rather than capturing tissue by themovement of two opposing doors, only a single rotatable door may beused. In such a variant, the door maybe rotatably coupled to a firstlongitudinal edge of the closed side of the capture assembly, the closedside and the door in the closed condition collectively defining thetissue capturing compartment. During use of such a device, the singledoor may be closed against a second longitudinal edge of the closed sideof the capture assembly to capture tissue of the heart valve leafletinside the tissue capturing compartment. Other devices that haveelements that rotate toward other rotatable or fixed structures togather leaflet tissue into a fold or pleat onto which a clip may beapplied are also contemplated herein.

Furthermore, although the devices have been described herein asincluding actuation rods with bumps that are moved proximally todisplace the clips and release them for application to captured tissue,the invention is not limited to such structures. For example, in onevariation thereof, the bump initially may be positioned adjacent theproximal end wall of the capture assembly, and the bump may be moveddistally to displace the clips and release them for application totissue captured in the tissue capturing compartment. In such anembodiment, the atraumatic tip of the device may have a through borethat accommodates the distal end of the actuation rod as it is moveddistally. The distal end of the actuation rod may remain captured by theatraumatic tip throughout the entire travel motion of the rod, therebyminimizing any lateral deflection of the rod that may prevent the bumpfrom displacing and releasing the clips during the clip deploymentprocess. In another variation, one or more bumps of the actuation rodmay initially be positioned facing away from the closed side of thecapture assembly, and the actuation rod may be rotated to bring the bumpor bumps into contact with the clips to displace and release them forapplication to tissue captured in the tissue capturing compartment.

Moreover, although the door-closing feature has been described above asa leaf spring, such as that shown in FIG. 8B, any structure may be usedto provide a force according to its bias that tends to close the doors.For example, the doors and the closed side of the capture assembly maybe constructed from a single contiguous piece of material, such as amemory metal or a strong, resilient metal or polymer, so as to provide aliving hinge operable to bias the doors to the closed condition.Alternatively, a hinge such as that shown in FIG. 2C may include a coilspring disposed around the pin, the coil spring having an bias thattends to close the doors.

Although the devices herein have been described in connection with theapplication of two clips onto a posterior leaflet, the inventioncontemplates the application of only one clip or any number of clipsgreater than one to any leaflet tissue during a single insertion of thedevice into a patient. In that regard, the tissue capturing compartmentmay be sufficiently long to accommodate any reasonable number of clipsin side-by-side relationship in the longitudinal direction of thecompartment, and all or less than all of the retained clips may beapplied in a single procedure.

Although the various delivery devices have been described herein inconnection with tightening the posterior leaflet of a mitral valve, allof the delivery devices may be used to repair other heart valveleaflets, such as the anterior leaflet of the mitral valve, or any othertissue of the body for which a reduction in the length of the tissuewould be beneficial.

Although the invention herein has been described with reference toparticular embodiments in which the device is inserted into the patientand advanced to the mitral valve using a transseptal approach, it is tobe understood that the invention contemplates embodiments in which thedevice reaches its target through another portion of the heart, such asthe apex of the heart, through a portion of the vasculature of thepatient, such as a subclavian artery, or through the aorta. In suchembodiments, some of the device components may have to be oriented in adifferent direction than described herein. For example, the inventioncontemplates embodiments in which the capture assembly approaches themitral valve from the downstream side as well as from the upstream sideof the valve.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

It will be appreciated that the various dependent claims and thefeatures set forth therein can be combined in different ways thanpresented in the initial claims. It will also be appreciated that thefeatures described in connection with individual embodiments may beshared with others of the described embodiments.

INDUSTRIAL APPLICABILITY

The present invention enjoys wide industrial applicability including,but not limited to, methods and devices for gathering tissue in apatient.

1. A method of gathering tissue in a patient, the method comprising:inserting an elongated device into the patient to a position adjacentthe tissue, the device including a capture assembly having a closed sideand a door rotatable between an open condition and a closed condition,the closed side and the door in the closed condition collectivelydefining a tissue capturing compartment; moving the door from the closedcondition to the open condition and engaging the door against thetissue; closing the door against the tissue to capture a portion of thetissue inside the tissue capturing compartment, the captured tissuebeing formed into a gathered configuration; and applying at least oneclip from the capture assembly to the captured tissue so as to hold thecaptured tissue substantially in the gathered configuration.
 2. Themethod as claimed in claim 1, wherein the tissue is a heart valveleaflet.
 3. The method as claimed in claim 1, wherein the captureassembly includes a spring element coupled to the door and biased tomove the door to the closed condition.
 4. The method as claimed in claim1, wherein the door includes at least one prong projecting therefrom,and the closing step includes grasping the captured tissue with the atleast one prong.
 5. The method as claimed in claim 1, wherein the doorincludes a portion with serrations, and the closing step includesgrasping the captured tissue with the serrations.
 6. The method asclaimed in claim 1, wherein the device includes a deployment elementattached to the door and operable by a user, and the moving stepincludes pulling the deployment element to rotate the door to the opencondition.
 7. The method as claimed in claim 1, wherein the captureassembly includes first and second doors rotatable between open andclosed conditions, and the closing step includes closing the first andsecond doors against the tissue to capture the portion of the tissueinside the tissue capturing compartment.
 8. The method as claimed inclaim 1, wherein the clip is biased to a substantially round conditionand is engaged with the door to hold the clip in an open condition, andthe applying step includes releasing the clip from engagement with thedoor, whereby the clip moves from the open condition to thesubstantially round condition.
 9. The method as claimed in claim 8,wherein the device includes an actuating rod movable relative to the atleast one clip, and the applying step includes moving the actuating rodto contact the at least one clip and releasing the at least one clip forapplication to the captured tissue.
 10. A device for gathering tissue ina patient, the device comprising: an elongated catheter having aproximal portion and a distal portion; and a capture assembly at thedistal portion of the catheter, the capture assembly including a closedside and a door rotatable between an open condition and a closedcondition, the closed side and the door in the closed conditioncollectively defining a tissue capturing compartment, the door beingoperable to capture a portion of the tissue in a gathered configurationwithin the tissue capturing compartment.
 11. The device as claimed inclaim 10, further comprising a spring element coupled to the door andbiased to move the door to the closed condition.
 12. The device asclaimed in claim 10, wherein the door has one edge rotatably connectedto the closed side of the capture assembly and a free edge opposite theone edge, the free edge including at least one prong projectingtherefrom.
 13. The device as claimed in claim 10, wherein the door hasone edge rotatably connected to the closed side of the capture assemblyand a free edge opposite the one edge, the free edge including aplurality of serrations.
 14. The device as claimed in claim 10, furthercomprising a deployment element attached to the door and extendingthrough the elongated catheter.
 15. The device as claimed in claim 10,wherein the capture assembly includes first and second doors rotatablebetween open and closed conditions, the first and second doors beingoperable to capture the portion of the tissue in a gatheredconfiguration within the tissue capturing compartment.
 16. The device asclaimed in claim 10, further comprising at least one clip releasablyheld in the tissue capturing compartment and adapted to be applied tothe captured tissue for holding the captured tissue in the gatheredconfiguration.
 17. The device as claimed in claim 16, wherein the clipis biased to a substantially round condition and is engaged with thedoor to hold the clip in an open condition.
 18. The device as claimed inclaim 17, wherein the clip has a first end and a second end, and thedoor includes a slot, the first end of the clip being engaged in theslot.
 19. The device as claimed in claim 18, wherein movement of thedoor to the open condition creates a biasing force in the clip tendingto move the door to the closed condition.
 20. The device as claimed inclaim 16, further comprising an actuating rod slidably disposed in thetissue capturing compartment, the actuating rod having a laterallyprojecting bump, and the clip being at least partially held in a travelpath of the bump, whereby movement of the bump through the travel pathcauses the bump to release the clip for application to the capturedtissue.
 21. The device as claimed in claim 20, wherein the bump has anoval cross-section, and a portion of the actuating rod adjacent the bumphas a round cross-section that is smaller than the oval cross-section inat least one direction.